Prometax: Withdrawal of the application to change the marketing authorisation



On 14 March 2012, Novartis Europharm Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for an extension of indication for Exelon and Prometax, to add the use of the transdermal patch for the treatment of mild to moderately severe dementia in patients with Parkinson's disease.

  • List item

    Questions and answers on withdrawal of the application for a change to the marketing authorisation for Exelon and Prometax (rivastigmine) (PDF/60.08 KB)

    First published: 19/04/2012
    Last updated: 21/05/2012

  • Key facts

    Product number
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    International non-proprietary name (INN) or common name
    • rivastigmine
    Active substance
    • rivastigmine
    Date of withdrawal
    Company making the application
    Novartis Europharm Limited
    Withdrawal type

    All documents

    Related information on withdrawals

    The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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